Study Description
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302. This is a global Phase 3, multicentre, double-blind, double-dummy, parallel-group extension study. It fulfils the Novartis commitment to provide post-trial access.
The study includes a double-blind and an open-label treatment phase:
Double-blind, double-dummy treatment continues from Week 68 (end of core study) until final database lock (DBL) of both core studies or until up titration. Participants remain on the same blinded regimen they were on during Treatment Period 2 of the preceding Phase 3 studies.
After final DBL of both core studies, treatment transitions to open-label.
Participants will continue treatment until commercial availability and reimbursement in their country, another access mechanism is available, or 4 years of extension treatment is completed.
Participants who discontinue treatment early or do not transition to commercial remibrutinib will enter a 4-week treatment-free safety follow-up.
Interventions
Remibrutinib
Eligibility Criteria
Key Inclusion Criteria:
* Signed informed consent must be obtained before any assessment is performed.
* Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
* Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Key Exclusion Criteria:
* Ongoing or planned use of prohibited HS or non-HS treatments.
* Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
* Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Novartis Investigative Site
Recruiting
CABA,C1428dzf,Argentina
Novartis Investigative Site
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CABA,C1012aay,Argentina
Novartis Investigative Site
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CABA,Buenos Aires,C1425bea,Argentina
Novartis Investigative Site
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Rosario,Santa Fe Province,S2000dbs,Argentina
Novartis Investigative Site
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Caba,Buenos Aires,C1119acn,Argentina
Novartis Investigative Site
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Sydney,New South Wales,2010,Australia
Novartis Investigative Site
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Melbourne,Victoria,3004,Australia
Novartis Investigative Site
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Parkville,Victoria,3050,Australia
Novartis Investigative Site
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Edmonton,Alberta,T6g 1c3,Canada
Novartis Investigative Site
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Québec,Quebec,G1v 4t3,Canada
Novartis Investigative Site
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London,Ontario,N6h 5l5,Canada
Novartis Investigative Site
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Montreal,Quebec,H1y 3l1,Canada
Novartis Investigative Site
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Beijing,100144,China
Novartis Investigative Site
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Lyon,69003,France
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Bochum,44791,Germany
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Muar town,Johor,84000,Malaysia
Novartis Investigative Site
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George Town,Pulau Pinang,10450,Malaysia
Novartis Investigative Site
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Ipoh,Perak,30450,Malaysia
Novartis Investigative Site
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Kota Kinabalu,Sabah,88586,Malaysia
Novartis Investigative Site
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Selangor Darul Ehsan,68100,Malaysia
Novartis Investigative Site
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Madrid,28041,Spain
Novartis Investigative Site
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Barcelona,Catalonia,08003,Spain
Novartis Investigative Site
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Las Palmas GC,35010,Spain
Total Skin and Beauty Dermatology Center PC
Recruiting
Birmingham,Alabama,35205,United States
Brittany Powell
Rajini Murthy
Arkansas Research Trials
Recruiting
North Little Rock,Arkansas,72117,United States
Scott Michael Dinehart
UP Medical Center H System
Recruiting
Pittsburgh,Pennsylvania,15213-3403,United States
Joe Kuanheng Tung
Center for Clinical Studies-Lee
Recruiting
Webster,Texas,77598,United States
Patricia C Lee
OnSite Clinical Solutions LLC
Recruiting
Huntersville,North Carolina,28078,United States
Nicole Seminara-Zambrzycka
Floridian Research Institute
Recruiting
Miami,Florida,33179,United States
Luis Javier Arechavaleta
Faride Ramos
Icahn School Of Med At Mount Sinai
Recruiting
New York,New York,10029,United States
Nadine Kaskas
Jillian Gray
Dundee Dermatology
Recruiting
West Dundee,Illinois,60118,United States
Paul Getz
JoAnn Hawkinson
Johnson Dermatology
Recruiting
Fort Smith,Arkansas,72916,United States
Sandra Johnson
Ctr for Dermatology Clinical Res
Recruiting
Fremont,California,95438,United States
Sunil Dhawan
Clinical Trials Research Institute
Recruiting
Thousand Oaks,California,91320,United States
Joanna Vargas
Navid Ezra
Endeavor Health
Recruiting
Glenview,Illinois,60077,United States
Megan Calderon
Shannon Ewing
Southern IN Clinical Trials
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New Albany,Indiana,47150,United States
Megan Landis
Misty Humphress
USC Keck School of Medicine
Recruiting
Los Angeles,California,90033,United States
Katrina Lee
Rudy Rocha
Olive View UCLA Medical Center
Recruiting
Sylmar,California,91342,United States
April Armstrong
University Of South Florida
Recruiting
Tampa,Florida,33612,United States
Ann Lin
Skin Specialists PC
Recruiting
Omaha,Nebraska,68144,United States
Joel Schlessinger
Cameron Dermatology
Recruiting
New York,New York,10023,United States
Michael Cameron
Yamiles Gonzalez
Optima Research Boardman
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Boardman,Ohio,44512,United States
Patrick Shannon
Apex Clinical Research Center LLC
Recruiting
Mayfield Heights,Ohio,44124,United States
Jorge Garcia-Zuazaga
Stacey Spigiel
Clinical Research Ctr of Carolinas
Recruiting
Charleston,South Carolina,29407,United States
Todd Schlesinger
Worldwide Contacts
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